Prostate CancerNCT03889119
Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer
A study testing Stereotactic Body Radiation Therapy (SBRT) radiation for prostate cancer utilizing the Elekta Versa or Agility System. in people with Prostate Cancer, run by Hoag Memorial Hospital Presbyterian at 1 site in United States.
Trial summary
The purpose of this study is to learn the long term efficacy and side effects associated with utilizing Stereotactic Body Radiation Therapy (SBRT) radiation for prostate cancer utilizing the Elekta Versa or Agility System. SBRT uses advanced imaging techniques to deliver targeted radiation to a tumor. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Stereotactic Body Radiation Therapy (SBRT) radiation for prostate cancer utilizing the Elekta Versa or Agility System.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2016to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of adenocarcinoma of the prostate History/physical examination with digital rectal examination of the prostate
- Histological evaluation of prostate biopsy with assignment of Gleason score to the biopsy material.
- Clinical stage T1-3 (AJCC 7th edition).
- Males age ≥ 18
- Patient must be able to provide study-specific informed consent prior to study entry.
- Willingness and ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire
Who cannot join
- Evidence of distant metastases
- Regional lymph node involvement
- Previous radical surgery (prostatectomy), cryosurgery, or HIFU for prostate cancer
- Previous pelvic irradiation, prostate brachytherapy
- Previous or concurrent cytotoxic chemotherapy for prostate cancer
- There are no exclusions due to co-morbid disease or illnesses except for patients with severe inflammatory bowel disease
- No life expectancy restrictions will apply
- Performance Status will not be considered
Trial locations and contacts
1 site in 1 country.
United States1 site
Hoag Memorial Hospital Presbyterian
Irvine, California, 92618
About this study
Official title: Stereotactic Body Radiation Therapy (SBRT) for the Management of Carcinoma of the Prostate: Quality of Life Data After Primary Stereotactic Body Radiation Therapy for Localized Prostate Cancer
The purpose of this study is to learn the long term efficacy and side effects associated with utilizing Stereotactic Body Radiation Therapy (SBRT) radiation for prostate cancer utilizing the Elekta Versa or Agility System. SBRT uses advanced imaging techniques to deliver targeted radiation to a tumor. The Elekta Versa and Agility Systems are approved by the Food and Drug Association (FDA) for SBRT treatment of cancer.
Traditional External beam radiation therapy (EBRT) for prostate carcinoma is typically done over the course of approximately 42-45 daily treatments SBRT is a way to condense this treatment into a course of 5 treatments, delivering more dose per day.
Read the detailed description
Prostate cancer is the most common cancer diagnosed in men, and ranks second in estimated deaths. The current standard of care for localized prostate cancer consists of observation, surgery or radiation therapy. From a radiation perspective, accepted options include external beam radiation therapy, brachytherapy, or a combination of those. Acceptable external beam radiation options are further defined as conventionally fractionated (over approximately 8-9 weeks), or moderately hypo-fractionated (over approximately 4-6 weeks).
Stereotactic body radiation therapy (SBRT) is a newer technique, allowing treatment to be delivered in an extremely hypo-fractionated regimen (i.e. in 5 fractions). Current consensus guidelines describe SBRT as "a cautious alternative to conventionally fractionated regimens at clinics with appropriate technology, physics, and clinical expertise."
The goal of any therapy is to maximize the effect of that treatment on cancer cells and minimize any effect on normal tissue. In radiation therapy, this is mainly done through dose targeting (i.e. limiting the radiation dose to the targets and minimizing dose to normal surrounding organs). Advancements in radiation therapy have allowed for better targeting, resulting in shrinking margins of treatment around cancer cells.
The therapeutic window can also be optimized through the use of fractionation (i.e. amount of dose delivered per day) in radiation therapy. Since cancerous and normal tissue cells respond differently to changes in fractionation, the therapeutic window could theoretically be improved by choosing a fractionation pattern to which cancer cells are more sensitive. Historical generalizations put cancer cells into the category of early responding tissues, which would make them more sensitive to cell death when radiation is delivered in a protracted fractionation pattern, such as over 8-9 weeks of radiation therapy.
However, studies have emerged which suggest that prostate cancer is unlike other cancers and reactive more like late responding tissues. With that in mind, prostate cancer cells could be more sensitive to high doses per fraction, which could provide a radiobiological advantage and a greater therapeutic window with the use of SBRT.
Very promising early results utilizing SBRT for prostate cancer treatment have been described in the literature, and multiple ongoing phase 3 trials are underway.
Aside from a potential therapeutic advantage, SBRT also offers a more cost effective solution to patients with prostate cancer, with less impact on their daily lives (only needing to come in for 5 treatments instead of 40-45 treatments).
Much of the literature on SBRT has been done utilizing the CyberKnife system. But the Elekta Versa HD and Agility Systems available at Hoag provides a unique opportunity for faster treatment delivery and 4D imaging during treatment. The Elekta Versa HD and Agility systems are approved by the FDA for SBRT treatment of cancer.
This study seeks to investigate biochemical failure rates for patients treated with SBRT utilizing Elekta machines, as well as obtain quality of life data and assess the intrafraction motion in approximately 15 patients for 5 years following SBRT.
- Conditions
- Prostate Cancer
- Being tested
- Stereotactic Body Radiation Therapy (SBRT) radiation for prostate cancer utilizing the Elekta Versa or Agility System.
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation Therapy (SBRT) radiation for prostate cancer utilizing the Elekta Versa or Agility System.Radiation
Also called Cyberknife
SBRT uses advanced imaging techniques to deliver targeted radiation to a tumor. The Elekta Versa and Agility Systems are approved by the Food and Drug Association (FDA) for SBRT treatment of cancer.
| Study group | Role | What they receive |
|---|---|---|
| Elekta Versa HD | Active comparator | This study seeks to investigate biochemical failure rates for patients treated with SBRT utilizing Elekta machines, as well as obtain quality of life data and assess the intrafraction motion in approximately 15 patients for 5 years following SBRT. Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT) radiation for prostate cancer utilizing the Elekta Versa or Agility System. |
| Agility Systems | Other | This study seeks to investigate biochemical failure rates for patients treated with SBRT utilizing Agility Systems, as well as obtain quality of life data and assess the intrafraction motion in approximately 15 patients for 5 years following SBRT. Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT) radiation for prostate cancer utilizing the Elekta Versa or Agility System. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary aim of this study is to examine biochemical failure rates after SBRT for patients with low, intermediate, and high risk localized non-metastatic prostate cancer.
The number of patients demonstrating biochemical failure will be assessed. Biochemical failure will be defined using the Phoenix definition (Roach et al. IJROBP 2006), which is defined as a rise above nadir PSA + 2 ng/ml.
Measured: 5 years
Secondary outcomes (1)
The secondary aim is to obtain quality of life data to examine the potential complications associated with SBRT: detailed symptom questionnaire
Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) (Chang J Urol 2011) total symptom score change from baseline will be assessed. This total score ranges from 0-60, with higher scores representing more symptoms.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start21 Oct 2016
- Primary completion31 Dec 2023
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- SBRT for the management of localized prostate cancer is a Phase II non-randomized clinical trial open to patients with biopsy proven localized prostate cancer. Patients will be deemed eligible for SBRT in any risk group categorization based upon the standard D'Amico stratification: * Low-risk: initial PSA \<10 and clinical stage T1c-T2a/b and biopsy Gleason grade 3+3 * Intermediate-risk: initial PSA \>10 but \<20 or clinical stage T2c or biopsy Gleason grade 3+4 or 4+3 * High-risk: initial PSA \>20 or clinical stage T3 or biopsy Gleason grade 4+4 or higher).
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoag Memorial Hospital Presbyterian
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Lin, Hoag Memorial Hospital Presbyterian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889119
- Sponsor's protocol ID
- 115-16-CA
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2019
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Body Radiation Therapy (SBRT) for the Management of Carcinoma of the Prostate: Quality of Life Data After Primary Stereotactic Body Radiation Therapy for Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT03889119
- Acronym / sponsor ID
- 115-16-CA
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hoag Memorial Hospital PresbyterianUniversity, hospital or other
- Study start
- 21 Oct 2016 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn the long term efficacy and side effects associated with utilizing Stereotactic Body Radiation Therapy (SBRT) radiation for prostate cancer utilizing the Elekta Versa or Agility System. SBRT uses advanced imaging techniques to deliver targeted radiation to a tumor. The Elekta Versa and Agility Systems are approved by the Food and Drug Association (FDA) for SBRT treatment of cancer.
Traditional External beam radiation therapy (EBRT) for prostate carcinoma is typically done over the course of approximately 42-45 daily treatments SBRT is a way to condense this treatment into a course of 5 treatments, delivering more dose per day.
Detailed description
Prostate cancer is the most common cancer diagnosed in men, and ranks second in estimated deaths. The current standard of care for localized prostate cancer consists of observation, surgery or radiation therapy. From a radiation perspective, accepted options include external beam radiation therapy, brachytherapy, or a combination of those. Acceptable external beam radiation options are further defined as conventionally fractionated (over approximately 8-9 weeks), or moderately hypo-fractionated (over approximately 4-6 weeks).
Stereotactic body radiation therapy (SBRT) is a newer technique, allowing treatment to be delivered in an extremely hypo-fractionated regimen (i.e. in 5 fractions). Current consensus guidelines describe SBRT as "a cautious alternative to conventionally fractionated regimens at clinics with appropriate technology, physics, and clinical expertise."
The goal of any therapy is to maximize the effect of that treatment on cancer cells and minimize any effect on normal tissue. In radiation therapy, this is mainly done through dose targeting (i.e. limiting the radiation dose to the targets and minimizing dose to normal surrounding organs). Advancements in radiation therapy have allowed for better targeting, resulting in shrinking margins of treatment around cancer cells.
The therapeutic window can also be optimized through the use of fractionation (i.e. amount of dose delivered per day) in radiation therapy. Since cancerous and normal tissue cells respond differently to changes in fractionation, the therapeutic window could theoretically be improved by choosing a fractionation pattern to which cancer cells are more sensitive. Historical generalizations put cancer cells into the category of early responding tissues, which would make them more sensitive to cell death when radiation is delivered in a protracted fractionation pattern, such as over 8-9 weeks of radiation therapy.
However, studies have emerged which suggest that prostate cancer is unlike other cancers and reactive more like late responding tissues. With that in mind, prostate cancer cells could be more sensitive to high doses per fraction, which could provide a radiobiological advantage and a greater therapeutic window with the use of SBRT.
Very promising early results utilizing SBRT for prostate cancer treatment have been described in the literature, and multiple ongoing phase 3 trials are underway.
Aside from a potential therapeutic advantage, SBRT also offers a more cost effective solution to patients with prostate cancer, with less impact on their daily lives (only needing to come in for 5 treatments instead of 40-45 treatments).
Much of the literature on SBRT has been done utilizing the CyberKnife system. But the Elekta Versa HD and Agility Systems available at Hoag provides a unique opportunity for faster treatment delivery and 4D imaging during treatment. The Elekta Versa HD and Agility systems are approved by the FDA for SBRT treatment of cancer.
This study seeks to investigate biochemical failure rates for patients treated with SBRT utilizing Elekta machines, as well as obtain quality of life data and assess the intrafraction motion in approximately 15 patients for 5 years following SBRT.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- SBRT for the management of localized prostate cancer is a Phase II non-randomized clinical trial open to patients with biopsy proven localized prostate cancer. Patients will be deemed eligible for SBRT in any risk group categorization based upon the standard D'Amico stratification: * Low-risk: initial PSA <10 and clinical stage T1c-T2a/b and biopsy Gleason grade 3+3 * Intermediate-risk: initial PSA >10 but <20 or clinical stage T2c or biopsy Gleason grade 3+4 or 4+3 * High-risk: initial PSA >20 or clinical stage T3 or biopsy Gleason grade 4+4 or higher).
| Arm | Type | Receives |
|---|---|---|
| Elekta Versa HD | Active comparator | Radiation: Stereotactic Body Radiation Therapy (SBRT) radiation for prostate cancer utilizing the Elekta Versa or Agility System.This study seeks to investigate biochemical failure rates for patients treated with SBRT utilizing Elekta machines, as well as obtain quality of life data and assess the intrafraction motion in approximately 15 patients for 5 years following SBRT. |
| Agility Systems | Other | Radiation: Stereotactic Body Radiation Therapy (SBRT) radiation for prostate cancer utilizing the Elekta Versa or Agility System.This study seeks to investigate biochemical failure rates for patients treated with SBRT utilizing Agility Systems, as well as obtain quality of life data and assess the intrafraction motion in approximately 15 patients for 5 years following SBRT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed diagnosis of adenocarcinoma of the prostate History/physical examination with digital rectal examination of the prostate
- Histological evaluation of prostate biopsy with assignment of Gleason score to the biopsy material.
- Clinical stage T1-3 (AJCC 7th edition).
- Males age ≥ 18
- Patient must be able to provide study-specific informed consent prior to study entry.
Key exclusion criteria (8 listed)
- Evidence of distant metastases
- Regional lymph node involvement
- Previous radical surgery (prostatectomy), cryosurgery, or HIFU for prostate cancer
- Previous pelvic irradiation, prostate brachytherapy
- Previous or concurrent cytotoxic chemotherapy for prostate cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) radiation for prostate cancer utilizing the Elekta Versa or Agility System.Also: CyberknifeSBRT uses advanced imaging techniques to deliver targeted radiation to a tumor. The Elekta Versa and Agility Systems are approved by the Food and Drug Association (FDA) for SBRT treatment of cancer. | Radiation | Agility Systems, Elekta Versa HD |
Primary outcome
The primary aim of this study is to examine biochemical failure rates after SBRT for patients with low, intermediate, and high risk localized non-metastatic prostate cancer.
Time frame: 5 years
The number of patients demonstrating biochemical failure will be assessed. Biochemical failure will be defined using the Phoenix definition (Roach et al. IJROBP 2006), which is defined as a rise above nadir PSA + 2 ng/ml.
1 secondary outcome
The secondary aim is to obtain quality of life data to examine the potential complications associated with SBRT: detailed symptom questionnaire
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Body Radiation Therapy (SBRT) radiation for prostate cancer utilizing the Elekta Versa or Agility System. in people with Prostate Cancer, run by Hoag Memorial Hospital Presbyterian at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary aim of this study is to examine biochemical failure rates after SBRT for patients with low, intermediate, and high risk localized non-metastatic prostate cancer. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.